Diagnostic Method

News & Analysis as of

Justice Breyer to Diagnostic Test Patentees – “Abandon Hope All Ye Who Enter Here.”

Kevin Noonan recently posted an article entitled “The Fantastical World of Justice Stephen Breyer” that demonstrates, via Breyer’s quotes during various oral arguments, his suspicion that the patent system is, for example,...more

Sequenom v. Ariosa Diagnostics: A Supreme Court Petition that Requests Clarification on the Patent Eligibility of Diagnostic...

UUnder the Patent Act, one can patent “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.” Common exceptions to what can be patented include laws of nature,...more

Supreme Court Asked to Clarify Limits on Diagnostic Method Patents

Arguing that the current state of the law weakens the patent system and poses a danger to life science innovators, biotechnology company, Sequenom, Inc., has filed a writ of certiorari with the U.S. Supreme Court, asking the...more

Another Diagnostic Patent Falls Under 101

In Genetic Techs Ltd v Merial LLC (Fed. Cir., April 8, 2016), the Federal Circuit invalidated yet another diagnostic patent for failing to satisfy 35 U.S.C. § 101 on the ground that the claims recite nothing more than a law...more

Methods Exploiting Junk DNA May Be Useful But Lack Patent Eligibility

Striking another blow against patent eligibility in the field of biotechnology, the Federal Circuit agreed with the district court that methods that use “junk DNA” to detect genetic variations lack patent eligibility under 35...more

Genetic Technologies Ltd. v. Merial L.L.C. (Fed. Cir. 2016)

The Federal Circuit affirmed the latest invalidation of genetic diagnostic claims last week, in Genetic Technologies Ltd. v. Merial L.L.C. While consistent with (and expressly relying upon) recent Federal Circuit precedent...more

Happy Birthday to Us! We are 7 Years Old!

In fact, Patents4Life’s birthday was in late March of 2009, but the earliest posts were short papers I wrote for an IP newsletter that no longer exists. However, the s. 101 storm clouds were gathering even then. One article...more

Sequenom Throws Diagnostic Method Patents At The Mercy Of The Supreme Court

It comes as no surprise that Sequenom has filed a petition for certiorari to the Supreme Court, asking the Court to review the Federal Circuit decision that upheld the district court decision that held its diagnostic method...more

Sequenom Files Petition for Cert. After Invalidation of Cff Patent

Sequenom, the loser in “Ariosa,” has filed a petition seeking Supreme Court review of the Fed. Cir.’s invalidation of the claims of US Pat. No. 6,258,540 as an attempt to claim a natural product, cffDNA....more

District Court Invalidates Cleveland Clinic Diagnostic Patents On Motion To Dismiss

Judge Gaughan of the U.S. District Court for the Northern District of Ohio granted the defendant’s motion to dismiss after finding three Cleveland Clinic Foundation diagnostic patents invalid under 35 USC § 101. While the...more

Judge Lourie Suggests Jepson Claims For Patent Eligibility

As reported previously, the Federal Circuit has denied rehearing in Ariosa Diagnostics, Inc. v. Sequenom, Inc. I wrote about Judge ‘Dyk’s opinion concurring in the denial but offering alternative views on patent eligibility...more

Important Development in Patent Subject Matter Eligibility for Diagnostic Method Claims: Federal Circuit Denies Sequenom Petition...

On December 2, 2015, the U.S. Court of Appeals for the Federal Circuit issued an order denying a petition for rehearing en banc in the closely watched Sequenom case. Earlier this year, on appeal from the U.S. District Court...more

Three Pressing Challenges for Personalized Medicine

Personalized medicine can be described as the science of targeted therapies. Advances in diagnostic and molecular medicine have made it possible to more precisely identify alternative treatment options for patients based on...more

Also In The News - Health Headlines - October 2015 #2

HHS Publishes Final Federal Health IT Strategic Plan 2015-2020 – On September 21, 2015, the Office of the National Coordinator for Health Information Technology (ONC) of HHS laid out the federal government’s final version of...more

Patent Subject Matter Eligibility – Impact on Litigation and Prosecution

Personalized medicine relies on diagnostic technologies to accurately evaluate a patient’s clinical or genetic signature to guide treatment decisions. Protecting innovation by patenting the diagnostic methods and tools that...more

Fed. Cir. Rules Requirements for Direct Infringement by Multiple Parties

In Akami Technologies v. Limelight Networks, App. No. 2009-1372, -1380, -1416, -1417 (Fed. Cir., August 13, 2015), the court, sitting en banc after a remand from the S. Ct., set out the requirements for direct infringement...more

Eisenberg Analyzes the 101 Exception for Patents Claiming Diagnostic

PatentlyO recently posted a nearly final draft of a paper writer by Professor Rebecca Eisenberg that will be published in the Journal of Science and Technology Law (note to author – fix fn 23). (A copy can be found at the end...more

Further Guidance from the PTO

And yet diagnostic methods are still wandering in the wilderness… The PTO has issued yet another revision of its Subject Matter Eligibility Guidance for Examiners. The ?rst of these Guidance documents arrived in March...more

The Impact of Ariosa Diagnostics v. Sequenom on the Patent Eligibility of Biomarker Detection Methods

Under the Patent Act, one can patent “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.” Common exceptions to what can be patented include laws of nature,...more

Federal Circuit Invalidates Another Diagnostic Patent

In Ariosa Diagnostics, Inc. v. Sequenom, Inc., Slip Op. 2014-1139, 2014-114 (Fed. Cir. June 12, 2015), the U.S. Court of Appeals for the Federal Circuit held that Sequenom’s U.S. Patent No. 6,258,540 (the ‘540 Patent) was...more

Patent for Technology that “Revolutionized Prenatal Care” Nonetheless Invalid as Patent Ineligible

The Federal Circuit Friday held in Ariosa Diagnostics, Inc. v. Sequenom, Inc. that Sequenom’s patent directed toward its MaterniT21 test—involving methods of detecting and using cell-free fetal DNA— was invalid for lack of...more

Fed Circuit: Sequenom’s Diagnostic Method Claims Invalid Under §101

On June 12, 2015, in Ariosa Diagnostics, Inc. v. Sequenom, Inc., the Federal Circuit affirmed the Northern District of California’s finding that the method claims in U.S. Patent 6,258,540 (‘540 patent) for detecting...more

Federal Circuit Holds Sequenom Diagnostic Method Patent Invalid Under 101

On Friday, June 12, 2015, the Federal Circuit issued its decision in Ariosa Diagnostics, Inc. v. Sequenom, Inc., affirming the district court's finding that Sequenom’s claims are invalid under 35 USC § 101. The court's...more

Waiting on Sequenom

As I write this there’s a voice in my head saying, “Be careful what you wish for!” but it has been five months since Sequenom was argued at the Federal Circuit, and the court has yet to issue its decision. In the meantime,...more

FDA Issues Guidance on Mobile Medical Devices

The Food and Drug Administration’s recent guidance on mobile medical applications illustrates the FDA’s growing efforts to combat emerging cybersecurity issues that affect patient safety. The guidance, issued in February...more

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